Statin Template Guidance Use of statins in primary and secondary prevention of vascular disease Endorsed by ABHB MTC for use in Gwent (October 2012)

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1 Statin Template Guidance Use of statins in primary and secondary prevention of vascular disease Endorsed by ABHB MTC for use in Gwent (October 2012)

2 Notes relating to this guidance This guidance serves as an aid to the implementation of NICE clinical guidelines on lipid modification (CG67) and type 2 diabetes (CG66). This guidance does not cover the management of familial hyperlipidaemia or other hereditary dyslipidaemias. NICE guidelines promote the use of simvastatin (or a drug of similar efficacy and acquisition cost) as first-line treatment for most people with established atherosclerotic vascular disease, those with diabetes and others with a high risk of cardiovascular disease (CVD). This has been found to be the most cost-effective intervention. The primary aim is to administer an evidence-based dose of statin (i.e. an adequate dose ) to all patients, as a starting point. For primary prevention, NICE advocate treatment with simvastatin 40 mg (or a drug of similar efficacy and acquisition cost) for most people. There may be additional advantages in gaining optimal cholesterol lowering in high-risk patients with established CVD and those with diabetes using higher doses of statin. It is important to rule out or treat any secondary causes of hyperlipidaemia, e.g. diabetes, hypothyroidism, chronic renal failure, nephrotic syndrome and high alcohol intake. The clinical indication and dose of statin should be clearly recorded and, where relevant, information exchanged between primary and secondary care. Please refer to the relevant Summary of Product Characteristics for prescribing data at: 2

3 Secondary prevention Treatment in established vascular disease All people with evidence of CVD: peripheral vascular disease, stroke/transient ischaemic attack, coronary heart disease (CHD) including angina, carotid endarterectomy, other arterial surgery or angioplasty and stents. Most people with diabetes aged over 40 (type 1 and type 2) (in type 2 diabetes and absence of obvious risk factors such as smoking, hypertension, family history, treat if > 20% risk 10 years). All should be given simvastatin 40 mg daily (preferably at night), or drug of similar efficacy and acquisition cost as initial treatment. Baseline tests Initial monitoring requirements (usually done at presentation - check to see if results recorded): Urea, electrolytes, creatinine Dipstick urinalysis TSH (cholesterol 7.5 mmol/l or if clinically indicated) Fasting blood glucose Check other prescribed drugs for side effects or interactions A fasting sample is required to measure triglyceride level and LDL cholesterol. Ideally patient should fast for 12 hours, consuming water only. Full LFTs are required for baseline measurement. ALT can then be routinely monitored subsequently, depending on local laboratory practice. Patients with CVD and/or diabetes (type 1 and 2) aged over 40 (in acute coronary syndrome consider immediate use of higher intensity statin) Establish baseline measurements for: Initial full fasting (i.e. 12 hours) lipid profile and LFTs Offer ALL people simvastatin 40 mg (or drug of similar efficacy and acquisition cost) daily (preferably taken at night) Repeat full fasting lipid profile and LFTs/ALT after ~3 months and at 12 months If statin is well tolerated, check lipids annually Lifestyle changes should be encouraged in parallel with drug treatment, especially smoking cessation. Other effective interventions in secondary prevention should be initiated where appropriate, e.g. low-dose aspirin, ß-blockers and ACEIs. Start with simvastatin 40 mg daily (or drug of similar efficacy and acquisition cost, as per NICE guidance). This gives substantial benefit. In type 2 diabetes where there is CVD and/or albuminuria, there may be additional advantages in more intense cholesterol lowering. The target for treatment in these patients is total cholesterol < 4 mmol/l or LDL-C < 2 mmol/l (see NICE CG66 and CG87). 3

4 Guidance notes for secondary prevention GMS targets an audit standard Treatment options Other treatment options Prescribing points The target of total cholesterol < 5 mmol/l remains an audit standard for those with CVD, but it should be recognised that even those with total cholesterol < 5 mmol/l at the time of, or prior to, their cardiovascular event will benefit from statin therapy and should receive it; i.e. patients with a total cholesterol of 4.5 mmol/l and CVD should still be given simvastatin 40 mg daily. Based on a combination of evidence, lipid lowering potency, cost and safety, the following is recommended for initial treatment: simvastatin 40 mg daily taken at night*. In patients on a more expensive statin, consideration should be given to switching to simvastatin. In acute coronary syndrome, consider immediate use of higher intensity statin. *NOTE: Simvastatin should generally be taken in the evening for maximum effect. If this recommendation impedes concordance, or for those who suffer from insomnia, the patient should be encouraged to take at the most convenient time. If patient is intolerant of simvastatin 40 mg daily: Reduce to simvastatin 20 mg at night, or use an alternative statin of similar efficacy and acquisition cost. Ezetimibe, fibrates, nicotinic acid and anion exchange resins may be considered for secondary prevention in people with CVD who are not able to tolerate statins. Total cholesterol > 4 mmol/l or LDL cholesterol > 2 mmol/l: First check compliance; studies have shown that compliance with statin therapy can be poor. If compliant, consider using a drug of similar efficacy and acquisition cost, taking into account patient s informed preference, co-morbidities, multiple drug therapy, and risk and benefit of treatment. The MHRA have warned that there is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. High-risk patients: People with acute coronary syndrome should be offered more intense treatment with a statin from the onset. Most evidence relates to atorvastatin 80 mg daily, although NICE also approve simvastatin 80 mg daily as a cost-effective option. This should be initiated by specialists in hospital. Type 2 diabetes and CVD or albuminuria: NICE recommend consideration of more intensive treatment than simvastatin 80 mg daily (i.e. with a more effective statin or ezetimibe in line with NICE guidance) to reach total cholesterol < 4 mmol/l or LDL cholesterol < 2 mmol/l. Statins require at least one to two weeks to become effective, and four-to-six weeks to exert their full effect. Check for compliance/concordance before assuming that the drug is ineffective. Repeat full fasting lipid profile at around 3 months and after any dose change. Thereafter, it is reasonable to repeat these annually; this aids compliance. Stop if ALT is > 3 times normal. Creatine kinase should only be measured if complaints of unusual muscular pains, weakness or cramps stop statin if symptoms are severe or if creatine kinase is > 5 times normal. Statin treatment should be reviewed in renal impairment. Simvastatin does not require dosage adjustment for mild or moderate renal impairment. Severe chronic kidney disease (egfr < 30 ml/min or creatinine clearance < 30 ml/min) requires specialist guidance. 4

5 Guidance notes for secondary prevention Drug interactions Ezetimibe Type 2 diabetes and very high triglycerides (i.e. > 4.5 mmol/l) despite statin therapy Or Type 2 diabetes and CVD or high-risk and high triglycerides (i.e mmol/l) In patients taking amiodarone, verapamil or amlodipine concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg daily due to an increased risk of myopathy. Care should be taken with diltiazem (simvastatin dose should not exceed 40 mg) and ciclosporin (simvastatin dose should not exceed 10 mg daily). Atorvastatin may also increase risk of myopathy with these drugs. Pravastatin and rosuvastatin are less likely to interact with these drugs. Simvastatin should be stopped while giving macrolide antibiotics (erythromycin/clarithromycin). Other drugs which require caution are azole antifungals (itraconazole, ketoconazole). See BNF for further details on drug interactions. Grapefruit juice should be avoided with simvastatin and atorvastatin. People with primary hypercholesterolaemia (heterozygous-familial and non-familial) should be considered for ezetimibe, as per NICE TA132. See Other treatment options on page 4. Consider adding fenofibrate (NICE CG66), though clear evidence of benefit is lacking. The MHRA urges considerable caution when fibrates are combined with statins due to the high risk of mypopathy/rhabdomyolysis. Gemfibrozil must not be combined with a statin. The MHRA has warned that there is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80 mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications and have not achieved their treatment goals on lower doses, when benefits are expected to outweigh the potential risks. Secondary causes such as chronic kidney disease, hypothyroidism, poor glucose control, liver disease and lifestyle factors, such as excess alcohol, may be a contributory factor in patients with raised triglycerides. If hypertriglyceridaemia remains refractory to this treatment, consider a trial of a licensed omega-3 fish oil preparation. The MHRA has warned that statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate. The risk appears to be mainly in patients already at increased risk of developing diabetes. However, the overall benefits of statins strongly outweigh any risks, including those at risk of developing diabetes or those with pre-existing diabetes. 5

6 Primary prevention Patients at high risk of a CVD event but who do not have clinical features of vascular disease are eligible for primary prevention. They should be identified systematically in general practice and offered treatment. Risk equations should be used for assessing CVD risk. Statin therapy is recommended for the primary prevention of CVD for adults who have a 20% or greater 10-year risk of developing CVD. Baseline tests Initial monitoring requirements: Urea, electrolytes, creatinine Dipstick urinalysis TSH (cholesterol 7.5 mmol/l and/or if clinically indicated) Fasting glucose Check other prescribed drugs for side effects or interactions A full fasting sample is required to measure triglyceride and LDL level. Patient should fast for 12 hours consuming water only. Full LFTs are required for baseline measurement only. Unless clinically indicated, ALT can be routinely monitored subsequently (depending on local laboratory recommendations). Systematically identify patients at high risk of CVD: age > 40 years, hypertension, smoking, ethnicity, family history of premature CVD (first degree relative: < 55 years, < 65 years), clinical signs of dyslipidaemia or abnormal lipid profile, central obesity It is important to emphasise lifestyle advice for all people, e.g. diet, exercise, smoking cessation Calculate the ratio of total:hdl cholesterol (fasting sample not required for total:hdl cholesterol ratio) Use an accredited CVD risk prediction chart to assess level of risk (suitably adjusted for family history, ethnicity etc. see notes) Establish baseline measurements for initial full fasting lipid profile and LFTs 1. Advise on appropriate dietary and lifestyle modification 2. Prescribe simvastatin 40 mg at night (or drug of similar efficacy and acquisition cost) If 10-year CVD risk < 20%: Lifestyle changes should be encouraged Repeat risk estimation within 5 years (at least) Lifestyle changes: Stop smoking More starchy carbohydrates, fruit and vegetables Less saturated fat, sugar and salt Reduce weight if overweight/obese Increase physical activity Reduce alcohol intake if > 21 units/week for men > 14 units/week for women Measure LFTs/ALT after ~3 months (repeating cholesterol level is unnecessary but may help with concordance) 6

7 Guidance notes for primary prevention Suspected familial hypercholesterolaemia (see NICE CG71) or other hereditary dyslipidaemia Risk assessment Treatment options AWMSG national indicator Other treatment options If unusual lipid profile (typically total cholesterol > 7.5 mmol/l, LDL-cholesterol > 4.9 mmol/l) where secondary causes have been ruled out, especially if strong family history of premature CVD (family history of MI aged younger than 50 years in second degree relative, aged less than 60 years in first degree relative), give dietary advice and seek specialist advice. Confirmation is needed with two measurements of LDL cholesterol. Family screening may be necessary subsequently. Absence of clinical signs (for example tendon xanthomata) does not exclude a diagnosis of familial hyperlipidaemia but the presence of these makes the diagnosis highly likely. A systematic strategy should be used to identify people aged who are likely to be at high risk of atherosclerotic CVD. Such a strategy may involve searching primary care records for risk factors. These people are largely managed in primary care. This risk cannot be estimated intuitively: use an accredited CVD risk assessment chart to help identify people at high risk of CVD. NICE has set this threshold as > 20% risk over 10 years. NICE advise that this should be presented to people numerically, in a way that gives information on absolute benefits and harms, using appropriate diagrams and text. See NICE CG67 and NPCi at for more detail. Based on a combination of evidence, lipid lowering potency, cost and safety, the following is recommended for treatment: Simvastatin 40 mg at night. For primary prevention, there is no evidence that more intense therapy improves outcome. Simvastatin should generally be taken in the evening for maximum effect. If this recommendation impedes concordance, or for those patients who suffer from insomnia, the patient should be encouraged to take at the most convenient time. AWMSG national indicator ( ) regarding lipid modifying drugs is based on items of low acquisition cost (LAC) statins as a percentage of all statin, ezetimibe and simvastatin/ezetimibe combination prescribing. If intolerant of simvastatin 40 mg at night: Reduce to simvastatin 20 mg at night, or use an alternative statin of similar efficacy and acquisition cost. Drug interactions In patients taking amiodarone, verapamil or amlodipine concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg daily due to an increased risk of myopathy. Care should be taken with diltiazem (do not exceed 40 mg dose). Atorvastatin may also increase risk of myopathy with these drugs. With ciclosporin, simvastatin dose should not exceed 10 mg daily. Pravastatin and rosuvastatin are less likely to interact with these drugs. Simvastatin should be stopped while giving macrolide antibiotics (erythromycin/clarithromycin). Other drugs which require caution are azole antifungals (itraconazole, ketoconazole). See BNF for further details on drug interactions. Grapefruit juice should be avoided with simvastatin and atorvastatin. Hospital specialists may treat more aggressively if deemed high risk (particularly where hereditary dyslipidaemia and/or premature family history CHD). 7

8 Resources 1. Moon and Bogle. Switching statins. BMJ 2006; 332: National Institute for Health and Clinical Excellence. TA94: Cardiovascular disease statins Available at: 3. British Cardiac Society, British Hypertension Society, Diabetes UK, HEART UK, Primary Care Cardiovascular Society, The Stroke Association. JBS 2: Joint British Societies Guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005; 91(Suppl V): v1 v Pedersen TR, Faergeman O, Kastelein JJP, et al. High-dose atorvastatin vs. usual-dose simvastatin for secondary prevention after myocardial infarction. JAMA 2005; 294: Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: Colhoun H, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004; 364: de Lemos JA, Blazing MA; Wiviott AD, et al. for the A to Z Investigators. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: Phase Z of the A to Z trial. JAMA 2004; 292: LaRosa JC, Grundy SM, Waters DD et al., the Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352: Cannon C P, Braunwald E., McCabe CH, et al., the Pravastatin or Atorvastatin Evaluation and Infection Therapy Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004; 350: Cholesterol Treatment Trialists' (CTT) Collaborators. Lancet 2005; 366: National Institute for Health and Clinical Excellence. TA132: Hypercholesterolemia ezetimibe Available at: National Institute for Health and Clinical Excellence. CG67: Lipid modification Available at: National Institute for Health and Clinical Excellence. CG66: Type 2 diabetes (partially updated by CG87) Available at: National Institute for Health and Clinical Excellence. CG71: Familial hypercholesterolaemia Available at: MHRA Drug Safety Update. Simvastatin: increased risk of myopathy at high dose (80 mg) Available at: MHRA Drug Safety Update. Statins: risk of hyperglycaemia and diabetes Available at: AWMSG. Statin template guidance: Use of statins in primary and secondary prevention of vascular disease. July Review date TBC 8

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